Summaries for Patients|16 January 2001

Combining Methotrexate with Prednisone To Treat Temporal Arteritis

The summary below is from the full report titled “Combined Treatment of Giant-Cell Arteritis with Methotrexate and Prednisone. A Randomized, Double-Blind, Placebo-Controlled Trial.” It is in the 16 January 2001 issue of Annals of Internal Medicine (volume 134, pages 106-114). The authors are JA Jover, C Hernández-García, IC Morado, E Vargas, A Bañares, and B Fernández-Gutiérrez.

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What is the problem and what is known about it so far?

Giant-cell arteritis (also called temporal arteritis) involves inflammation of large and medium-sized arteries (vasculitis). This condition occurs in elderly people and can lead to sudden blindness when the inflammation involves the temporal artery, an artery located on the side of the head that supplies blood to the eye. Prompt treatment can prevent blindness. Standard therapy for giant-cell arteritis consists of large doses of the drug prednisone, followed by a gradual decrease in the dose. Patients need to take a low dose of prednisone for an average of 2 years. Unfortunately, in many patients, symptoms (including headache, changes in vision, and tenderness over the temporal artery) return as the dose of prednisone is lowered, or side effects from the prednisone develop. Thus, better ways to treat giant-cell arteritis are needed. Methotrexate is a drug that interacts with the immune system and is useful in treating other forms of vasculitis. Some reports suggest that it may help decrease the amount of prednisone needed to treat giant-cell arteritis.

Why did the researchers do this particular study?

To get more information on whether methotrexate plus prednisone is a better way to treat giant-cell arteritis than prednisone alone.

Who was studied?

The study included 42 patients with newly diagnosed giant-cell arteritis in a hospital in Spain.

How was the study done?

All patients received standard prednisone treatment. The researchers randomly assigned patients to receive either methotrexate or placebo in addition to prednisone. The placebo looked like the methotrexate but contained no active ingredients. Neither the patients nor the researchers knew which treatment a patient received until the study was completed. The researchers collected information on patients' symptoms, the total dose of prednisone they needed over the course of the treatment, and the number of side effects that patients experienced.

What did the researchers find?

Of patients who received methotrexate and prednisone, 45% had at least one relapse of arteritis compared with 84% of the patients who received placebo and prednisone. Patients who took methotrexate also needed less prednisone over the course of treatment than those who took placebo. The number and severity of side effects were similar in the two groups.

What were the limitations of the study?

Some of the patients did not complete the study; this limited the power of the study to reveal differences in side effects between the two groups.

What are the implications of the study?

Methotrexate combined with prednisone is more effective at preventing relapses of giant-cell arteritis than prednisone alone. Patients who receive methotrexate also appear to need less prednisone over the course of treatment but still experience some side effects from prednisone therapy.

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